Ignite Creation Date:
2024-05-05 @ 11:21 PM
Last Modification Date:
2024-10-26 @ 10:33 AM
Study NCT ID:
NCT01319578
Status:
COMPLETED
Last Update Posted:
2011-11-15
First Post:
2011-03-03
Brief Title:
PD Study to Assess Phosphate Binding Characteristics of K2CG Chewing Gum
Sponsor:
Denver Nephrologists PC
Organization:
Denver Nephrologists PC
Study Overview
Official Title:
A Single Blind Pharmacodynamic Study to Assess the Phosphate Binding Characteristics of K2CG Chewing Gum
Status:
COMPLETED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The specific purpose of this study is to describe the characteristics of the K2CG chewing gum specifically as it relates to duration of gum chewing exposure timing of gum chewing in relation to a meal and dose of K2CG chewing gum
Detailed Description:
Previous studies have demonstrated that salivary phosphate levels are elevated in patients with CKD and that there is a direct and linear correlation between serum phosphorus and salivary phosphorus K2CG chewing gum may provide an alternative approach to treating patients with elevated phosphate levels However data regarding the pharmacodynamic effect of the K2CG chewing gum on salivary phosphorus is lacking as such this study seeks to examine the phosphate binding characteristics of K2CG chewing gum with 2 different amounts of chitosan and varying exposure time in the fasting and fed condition
A precise knowledge of the pharmacodynamic effect of the K2CG chewing gum on salivary phosphorus is expected to provide information necessary to plan and conduct a subsequent interventional trial with K2CG chewing gum in patients with both Chronic Kidney Disease and ESRD Specifically quantification of the amount of salivary phosphorus that binds to 3 formulations of chitosan loaded chewing gum 20 mg 40 mg and 60 mg with varying exposure times will inform the optimal duration of exposure relative to gum size The effect of gum size will be further explored via the use of two different sizes of placebo chewing gum 17 g and 20 g sizes Additionally it is a specific aim of this study to assess whether chewing gum in the fasted vs fed state affects the binding characteristics of chitosan loaded chewing gum
This study is a pharmacodynamic study to characterize the phosphate binding capabilities of three different doses of K2CG chewing gum 20mg 40mg 60mg and one placebo chewing gum 17 g Thirty-six subjects will be enrolled across three renal function group based on estimated glomerular filtration rate
Study assessments will occur over four study visit days Visit 2 Visit 3 Visit 4 and Visit 5 Fasting study procedures will occur in the morning of each visit day and non-fasting procedures will occur following the administration of a standardized meal on the same day All subjects will receive three doses of K2CG chewing gum and one placebo 20 mg dose at Visit 2 17 g placebo at Visit 3 40 mg dose at Visit 4 and 60 mg dose at Visit 5 Subjects will not be aware of the specific gum dose or size at any study visit single blind The duration of gum chewing and timing of salivary collections will vary within each group
Saliva will be collected at specified time points throughout the trial Fasting salivary phosphorus must be collected with nothing to eat or drink for at least 2 hours
A precise knowledge of the pharmacodynamic effect of the K2CG chewing gum on salivary phosphorus is expected to provide information necessary to plan and conduct a subsequent interventional trial with K2CG chewing gum in patients with both Chronic Kidney Disease and ESRD Specifically quantification of the amount of salivary phosphorus that binds to 3 formulations of chitosan loaded chewing gum 20 mg 40 mg and 60 mg with varying exposure times will inform the optimal duration of exposure relative to gum size The effect of gum size will be further explored via the use of two different sizes of placebo chewing gum 17 g and 20 g sizes Additionally it is a specific aim of this study to assess whether chewing gum in the fasted vs fed state affects the binding characteristics of chitosan loaded chewing gum
This study is a pharmacodynamic study to characterize the phosphate binding capabilities of three different doses of K2CG chewing gum 20mg 40mg 60mg and one placebo chewing gum 17 g Thirty-six subjects will be enrolled across three renal function group based on estimated glomerular filtration rate
Study assessments will occur over four study visit days Visit 2 Visit 3 Visit 4 and Visit 5 Fasting study procedures will occur in the morning of each visit day and non-fasting procedures will occur following the administration of a standardized meal on the same day All subjects will receive three doses of K2CG chewing gum and one placebo 20 mg dose at Visit 2 17 g placebo at Visit 3 40 mg dose at Visit 4 and 60 mg dose at Visit 5 Subjects will not be aware of the specific gum dose or size at any study visit single blind The duration of gum chewing and timing of salivary collections will vary within each group
Saliva will be collected at specified time points throughout the trial Fasting salivary phosphorus must be collected with nothing to eat or drink for at least 2 hours
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None